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ARROW IPN039788Recalls & reported problems

Teleflex Incorporated · UltraFlex(TM) IAB · Class 2

Quick summary

This Teleflex UltraFlex intra-aortic balloon pump catheter sits in an artery to support the heart during surgery or critical care. The 29 reports mostly describe the balloon not inflating properly, kinking, folding or rupturing, and helium or blood leaking into the tubing, sometimes forcing the catheter to be removed and replaced. Reports mention 4 injuries and no deaths. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
29
Deaths reported
0
Injuries reported
4
Recalls naming it
0

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 10801902145731), received between Aug 12, 2022 and Aug 1, 2023 — classified as 4 injuries, 25 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (9 reports).

27 other recalls cover devices cleared under the same FDA submission (K000729); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Gas/Air Leak9
  • Inflation Problem4
  • Material Twisted/Bent3
  • Break2
  • Fluid/Blood Leak2
  • Physical Resistance/Sticking2
  • Burst Container or Vessel1
  • Connection Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions26
  • Insufficient Information2
  • Foreign Body In Patient1

Recent adverse event reports

The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 1, 2023Gas/Air Leak; Gas/Air Leak

    REPORTED AS "IAB RUPTURE / ABRASION". THE REPORT STATES THAT BROWN-TINGED CONDENSATION WAS NOTED IN THE TUBING. THE PUMP ALSO ALARMED FOR "HELIUM LOSS 2". AS A RESULT, THE IAB WAS REMOVED AND A 2ND IAB WAS INSERTED AT THE SAME INSERTION SITE. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "CRITICAL" PRIOR TO AND AFTER THE EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17435011 ↗
  • MalfunctionJul 24, 2023Material Twisted/Bent; Material Twisted/Bent

    IT WAS REPORTED THAT "AFTER 3 MINUTES OF USE, THE MACHINE FREQUENTLY ALARMS AND THE CATHETER MAY BE KINKED. ADJUSTING THE EQUIPMENT AND CATHETER CANNOT SOLVE THE PROBLEM. AFTER REPLACING THE CATHETER, THE PROBLEM WAS RESOLVED". THE 2ND CATHETER WAS INSERTED AT THE SAME INSERTION SITE. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17383102 ↗
  • MalfunctionJul 18, 2023Inflation Problem; Inflation Problem

    IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THE BALLOON DID NOT FULLY UNWRAP. AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. IF FURTHER INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.

    Patient problems: Insufficient Information

    MAUDE report 17342791 ↗
  • MalfunctionJul 13, 2023Material Twisted/Bent; Material Twisted/Bent

    IT WAS REPORTED THAT "THE SURGEON, IMPLANTED THE BALLOON THROUGH A SHEATH AND WAS UNABLE TO FULLY IMPLANT IT INTO THE IDEAL POSITION. HOWEVER, BY MOVING THE BALLOON BACK AND FORTH, IT WAS STILL UNABLE TO BE IMPLANTED INTO THE IDEAL POSITION. WITHDRAW THE BALLOON, CONNECT THE ONE-WAY VALVE, RETRACT THE EXHAUST, AND INSERT IT AGAIN, BUT IT CANNOT BE FULLY INSERTED. IMMEDIATELY WITHDRAW THE BALLOON AND DISCOVER THAT IT HAS BEEN FOLDED. REPLACE IT WITH A NEW CATHETER AND INSERT IT NORMALLY." THE 2ND CATHETER WAS INSERTED AT THE SAME INSERTION STIE. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17317179 ↗
  • InjuryJul 5, 2023Fluid/Blood Leak; Fluid/Blood Leak

    IT WAS REPORTED THAT AN IAB WAS INSERTED ON (B)(6) 2023 IN THE LEFT AXILLARY ARTERY WITHOUT DIFFICULTY. A CONTINUOUS HEPARIN INFUSION WAS ADMINISTERED APPROXIMATELY 8 HOURS AFTER INSERTION. THE PRIMARY NURSE NOTED BLOOD IN THE HELIUM PATHWAY AT APPROXIMATELY 1215 ON (B)(6) 2023. AS A RESULT, THE IAB WAS SUCCESSFULLY REMOVED AT BEDSIDE WITHOUT DIFFICULTY. AT THAT TIME, THE CARE TEAM ELECTED TO NOT IMMEDIATELY REPLACE THE IAB TO DETERMINE NECESSITY OF THERAPY. THE PATIENTS HEMODYNAMICS DECLINED OVER THE NEXT 24 HOURS AND ON (B)(6) 2023 AN IAB WAS INSERTED IN THE RIGHT FEMORAL ARTERY IN THE CARDIAC CATH LAB WITHOUT DIFFICULTY. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17259132 ↗
  • MalfunctionJun 26, 2023Fluid/Blood Leak; Fluid/Blood Leak

    REPORTED AS "RUPTURED IAB". IT WAS REPORTED THAT APPROXIMATELY 48 HOURS AFTER INSERTION OF THE IAB AT THE LEFT AXILLARY SITE, BLOOD WAS NOTED IN THE DRIVELINE. AS A RESULT, THE IAB WAS REMOVED AND A 2ND IAB WAS INSERTED AT THE SAME INSERTION SITE. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17198430 ↗
  • MalfunctionJun 19, 2023Gas/Air Leak; Gas/Air Leak

    IT WAS REPORTED THAT ON THE 5TH DAY OF IABP THERAPY, THE NURSE NOTED THAT THERE WAS BLOOD IN THE HELIUM PATHWAY OF THE IAB. AS A RESULT, THE IAB WAS REMOVED AND A 2ND IAB WAS INSERTED AT THE SAME INSERTION SITE. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17152108 ↗
  • MalfunctionApr 11, 2023Material Rupture; Material Rupture

    IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THE BALLOON RUPTURED. THE ISSUE WAS RESOLVED BY REMOVING THE CATHETER. A 2ND CATHETER WAS NOT INSERTED. THERE WAS A REPORT OF PATIENT DEATH. THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT'S DEATH. THE MEDICAL JUDGEMENT WAS MADE BY THE DOCTOR IN CHARGE. INQUIRIES WERE MADE TO THE CUSTOMER REGARDING ADDITIONAL INFORMATION ABOUT THE DEATH BUT THE CUSTOMER DID NOT RESPOND. IF ADDITIONAL INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16713812 ↗
  • MalfunctionJan 30, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

    IT WAS REPORTED: "CCU ON THE THIRD FLOOR OF WUHAN ASIAN HEART HOSPITAL. THE NEXT DAY AFTER THE CATHETER WAS INSERTED, THE NURSE FOUND THAT THE MACHINE ALARMED, AND STOP WORKING, AND AFTER CHECK IT, IT WAS FOUND THAT THE PROTECTIVE SLEEVE OF THE BALLOON TO THE SHEATH CONNECTOR WAS LOOSE, AND THE BALLOON WAS EJECTED. THEN THE DOCTOR REMOVED THE CATHETER". ADDITIONAL INFORMATION HAS BEEN REQUESTED TO THE CUSTOMER FOR CLARIFICATION OF THE REPORTED ISSUE. NO RESPONSE RECEIVED AT TIME OF REPORT. PATIENT CONDITION REPORTED AS "FINE".

    Patient problems: Insufficient Information

    MAUDE report 16267774 ↗
  • MalfunctionNov 30, 2022Connection Problem; Device Misassembled During Manufacturing /Shipping; Connection Problem; Device Misassembled During Manufacturing /Shipping

    IT WAS REPORTED THAT THE TUBING CONNECTOR OF THE HELIUM ADAPTOR WAS FOUND UPSIDE DOWN. FURTHER INFORMATION STATES THAT "[THE CLINICIAN] HAD ALREADY INSERTED THE CATHETER INTO THE PATIENT, THEN THE CONNECTION BETWEEN OUR ADAPTOR AND PORT OF THE MAQUET IABP WAS FOUND AFTER THEY WANTED TO PLUG IN AND STARTED PUMPING". NO REPORT OF HARM OR INJURY TO THE PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15889814 ↗
  • MalfunctionNov 29, 2022Material Integrity Problem; Material Integrity Problem

    REPORTED AS "BALLOON DID NOT DEPLOY". THE REPORT STATES THAT THE "IABP PLACED IN CATH LAB. ALARMING POSSIBLE HELIUM LEAK SINCE ADMISSION WITH NO AUGMENTING WAVEFORM. HELIUM CANISTER CHANGED, PUMP EXCHANGED, IAB PULLED OUT BY [PHYSICIAN]. THE BALLOON WAS VIEWED AND INFLATED MANUALLY WITH PROXIMAL BALLOON NOTED TO BE TWISTED. BALLOON DID NOT INFLATE FULLY. NO HARM OR INJURY TO THE PATIENT. NO INTERVENTION NECESSARY, PATIENT REMAINED STABLE".

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15880665 ↗
  • MalfunctionNov 10, 2022Inflation Problem; Inflation Problem

    REPORTED AS "HIGH PRESSURE, FAILURE TO UNWRAP". AS REPORTED BY A TELEFLEX CLINICAL SUPPORT SPECIALIST, "PATIENT WAS EMERGENT, STEMI AND WHEN [THE PHYSICIAN] INSERTED THE IAB AND THE STAFF STARTED THE PUMP, IT WAS NOTED THAT THE MEMBRANE WAS NOT OPENING THE WHOLE WAY. THEY RECEIVED HIGH PRESSURE ALARM, SO THEY DECIDED TO REMOVE THE PROBLEMATIC IAB/SHEATH OVER A WIRE AND INSERT A SECOND NEW SHEATH/IAB. PATIENT WAS HEMODYNAMICALLY STABLE WITH GTTS DURING THE DOWN TIME. THE SECOND IAB WORKED AS EXPECTED AND THE PATIENT REMAINS ON THE PUMP IN THE ICU WITH NO ISSUES/NO ALARMS". THE SECOND IAB WAS INSERTED AT THE SAME INSERTION SITE. THE PATIENT CONDITION IS REPORTED AS "FINE".

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15775865 ↗
  • MalfunctionNov 10, 2022Gas/Air Leak; Gas/Air Leak

    IT WAS REPORTED THAT "AFTER 8 MINUTES OF USE, THE MACHINE FREQUENTLY ALARMED FOR HELIUM LOSS. THE ISSUE COULD NOT BE RESOLVED BY ADJUSTING THE EQUIPMENT AND THE CATHETER. AS A RESULT, THE CATHETER WAS REPLACED, AND THE PROBLEM WAS SOLVED". THE SECOND CATHETER WAS INSERTED AT THE SAME INSERTION SITE. THE PATIENT CONDITION IS REPORTED AS "FINE".

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15771561 ↗
  • MalfunctionNov 4, 2022Gas/Air Leak; Gas/Air Leak

    IT WAS REPORTED THAT "AFTER 3 MINUTES OF USE, THE MACHINE FREQUENTLY ALARMED FOR HELIUM LOSS. THE ISSUE COULD NOT BE RESOLVED BY ADJUSTING THE EQUIPMENT AND THE CATHETER. AS A RESULT, THE CATHETER WAS REPLACED, AND THE PROBLEM WAS SOLVED". ADDITIONAL INFORMATION STATES THAT THE SECONDARY CATHETER WAS INSERTED AT THE SAME INSERTION SITE. THE PATIENT CONDITION IS REPORTED AS "FINE".

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15726315 ↗
  • MalfunctionNov 2, 2022Burst Container or Vessel; Burst Container or Vessel

    IT WAS REPORTED THAT AN "ULTRAFLEX 40CC BALLOON RUPTURED IN THE ICU AFTER TWO HOURS OF WORKING." A SECOND IAB WAS INSERTED AT THE SAME INSERTION SITE. NO REPORTED DELAY OF TREATMENT. NO REPORT OF PATIENT HARM OR INJURY. PATIENT STATUS REPORTED AS "FINE".

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15715589 ↗
  • MalfunctionOct 27, 2022Gas/Air Leak; Gas/Air Leak

    THE REPORT STATES "AFTER 3 MINUTES OF USE, THE MACHINE FREQUENTLY ALARMED FOR HELIUM LOSS. THE ISSUE COULD NOT BE RESOLVED BY ADJUSTING THE EQUIPMENT AND THE CATHETER. AS A RESULT, THE CATHETER WAS REPLACED, AND THE PROBLEM WAS SOLVED. THE SECOND CATHETER WAS INSERTED AT THE SAME INSERTION SITE". THE CURRENT PATIENT CONDITION IS REPORTED AS "FINE".

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15685010 ↗
  • MalfunctionOct 17, 2022Material Twisted/Bent; Material Twisted/Bent

    IT WAS REPORTED THAT "THE BALLOON COULD NOT MOVE FORWARD NORMALLY AFTER INSERTION, AFTER CHECKING IT, IT WAS FOUND THAT THE CATHETER WAS SEVERELY KINKED AND COULD NOT BE USED NORMALLY, SO A NEW CATHETER WAS REPLACED FOR SMOOTH INSERT." ADDITIONAL INFORMATION STATES THAT THE SECONDARY CATHETER WAS INSERTED AT THE SAME INSERTION SITE. NO REPORT OF PATIENT HARM OR INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15615945 ↗
  • MalfunctionOct 17, 2022Break; Break

    THE REPORT STATES "ON (B)(6), 2022, (B)(6) OPENED THE CATHETER PACKAGE AND IMPLANTED IT NORMALLY. DURING THE OPERATION, IT WAS FOUND THAT THE CONNECTION BETWEEN THE CATHETER HEAD AND THE BALLOON TUBE WAS BROKEN AND COULD NOT BE USED NORMALLY". A NEW CATHETER WAS INSERTED AT THE SAME INSERTION SITE. NO REPORT OF PATIENT HARM OR INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15615925 ↗
  • MalfunctionOct 12, 2022Leak/Splash; Leak/Splash

    IT WAS REPORTED THAT "A LEAK WAS FOUND ON THE CATHETER WHILE IN USE ON THE PATIENT. AS A RESULT, A NEW IAB WAS INSERTED AT THE SAME INSERTION SITE. THERE WAS NO REPORT OF PATIENT COMPLICATIONS, SERIOUS INJURY OR DEATH".

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15587870 ↗
  • InjurySep 20, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

    IT WAS REPORTED "IAB ABRASION". ADDITIONAL INFORMATION STATED "THE PATIENT HAD A LEFT AXILLARY IAB THAT WAS PLANNED TO BE REMOVED. [THE PHYSICIAN] FIRST TRIED TO PULL THE IAB BACK THROUGH THE SHEATH AND THE CHIEF OF PERFUSION WAS IN THE OR AND TOLD HIM THAT EVERYTHING HAD TO COME OUT AND HE COULD USE A WIRE IN THE CENTRAL LUMEN TO MAINTAIN ACCESS TO HELP WITH HIS DESIRED CLOSURE TECHNIQUE. HE WAS ABLE TO PASS THE WIRE AND THEN HE MET RESISTANCE AS THE IAB REMAINED ABOUT 3 INCHES IN THE AXILLARY ARTERY". IT WAS REPORTED THAT ANOTHER IAB WAS NOT INSERTED AS THE PROCEDURE WAS PLANNED FOR REMOVAL OF THE IAB. PATIENT CONDITION REPORTED AS "FINE" POST SURGERY. ASSOCIATED MDR 3010532612-2022-00363.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15459947 ↗
  • MalfunctionSep 19, 2022Gas/Air Leak; Gas/Air Leak

    IT WAS REPORTED "AFTER 3 MINUTES OF USE, THE MACHINE FREQUENTLY ALARMS THAT HELIUM MAY LEAK. THE ADJUSTMENT EQUIPMENT AND THE CATHETER CANNOT SOLVE THE PROBLEM. AFTER THE CATHETER IS REPLACED, THE PROBLEM IS SOLVED. IN VITRO EXPERIMENT, IT IS DETERMINED THAT THE CONNECTION HUB OF CATHETER LEAK". ADDITIONAL INFORMATION RECEIVED STATED THAT SECOND IAB WAS INSERTED AT THE SAME SITE. NO PATIENT INJURY, HARM, OR CONSEQUENCE REPORTED. PATIENT CONDITION REPORTED AS "FINE".

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15452243 ↗
  • InjurySep 16, 2022Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

    IT WAS REPORTED "WUHAN ASIAN HEART HOSPITAL ENCOUNTERED VERY SERIOUS RESISTANCE WHEN WITHDRAWING THE CATHETER AND THE CATHETER WAS UNABLE TO TAKE OUT. DSA SHOWED THAT THERE WAS A PROBLEM WITH THE BALLOON TIP. AFTER THAT, THE PATIENT WAS IMMEDIATELY TRANSFERRED TO SURGERY TO OPEN THE ARTERY AND TAKE OUT THE CATHETER". ADDITIONAL INFORMATION RECEIVED STATED THAT ANOTHER IAB WAS NOT INSERTED. PATIENT CONDITION REPORTED AS "FINE".

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15442706 ↗
  • MalfunctionSep 16, 2022Gas/Air Leak; Gas/Air Leak

    IT WAS REPORTED THAT "AFTER THE CATHETER WAS IMPLANTED DURING THE OPERATION, THE MACHINE ALARMED (GAS LEAK ALARM). AFTER THE CATHETER WAS TAKEN OUT, THE CATHETER WAS FOUND LEAKAGE". ADDITIONAL INFORMATION STATED THAT THE CATHETER WAS REPLACED WITH A NEW IAB. THE NEW IAB WAS INSERTED AT THE SAME INSERTION SITE. PATIENT CONDITION REPORTED AS "FINE".

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15442705 ↗
  • MalfunctionSep 16, 2022Gas/Air Leak; Gas/Air Leak

    IT WAS REPORTED THAT "WHEN THE DOCTOR GAVE THE BALLOON COUNTERPULSATION TREATMENT, THE INSTRUMENT DISPLAYED AN ALARM. IT WAS FOUND THAT THE HELIUM CONNECTING PIPE WAS NOT CONNECTED TIGHTLY. AFTER THE CATHETER WAS REPLACED, THE ALARM DISAPPEARED AND NO HARM WAS CAUSED TO THE PATIENT". ADDITIONAL INFORMATION RECEIVED STATED THAT "THE SECOND IAB WAS INSERTED AT THE SAME INSERTION SITE". NO PATIENT INJURY, HARM, OR CONSEQUENCE REPORTED. PATIENT CONDITION REPORTED AS "FINE".

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15440114 ↗
  • MalfunctionAug 29, 2022Gas/Air Leak; Gas/Air Leak

    IT WAS REPORTED THAT "WHEN THE BALLOON WAS IMPLANTED, THE MACHINE WAS STARTED, AFTER 2 MINUTES THE ALARM "HELIUM LEAKAGE" OCCURRED. THE PROBLEM WAS SOLVED AFTER REPLACING THE CATHETER". ADDITIONAL INFORMATION RECEIVED STATED THAT THE IAB CATHETER WAS PLACED IN THE LEFT FEMORAL ARTERY. NO PATIENT INJURY, HARM, OR CONSEQUENCE FROM REPLACING THE CATHETER. PATIENT CONDITION WAS REPORTED AS "FINE".

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15317301 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K000729. One submission often covers many models, so check the product and lot details in each record.

  • Z-1879-2024 · Apr 29, 2024 · Open, Classified
    Arrow UltraFlex Intra-Aortic Balloon Catheter Kit, a) REF IAB-06830-U; b) REF IAB-06840-U; c) REF IAB-06850-U
  • Z-1880-2024 · Apr 29, 2024 · Open, Classified
    Arrow Ultra 8 IAB Intra-Aortic Balloon Catheter Kit, a) REF IAB-05830-U; b) REF IAB-05840-U
  • Z-1062-2016 · Feb 10, 2016 · Terminated
    Percutaneous Insertion Tray; Product Code: IAK-06845 The Arrow IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during di
  • Z-1056-2016 · Feb 10, 2016 · Terminated
    Ultra 8 IAB: 8Fr 30cc; Product Code: IAB-05830-U The Arrow IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diasto
  • Z-1059-2016 · Feb 10, 2016 · Terminated
    UltraFlex IAB: 7.5Fr 30cc; Product Code: IAB-06830-U The Arrow IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during di
  • Z-1058-2016 · Feb 10, 2016 · Terminated
    Ultra 8 IAB: 8Fr 40cc; Product Code: IAB-05840-U The Arrow IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diasto
  • Z-1060-2016 · Feb 10, 2016 · Terminated
    UltraFlex IAB: 7.5Fr 40cc; Product Code: IAB-06840-U The Arrow IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during di
  • Z-1064-2013 · Nov 27, 2012 · Terminated
    Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 30 cc; Product Number: IAB-05830-LWS. The IAB is utilized for intra-aortic balloon counter-pulsation t
  • Z-1065-2013 · Nov 27, 2012 · Terminated
    Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 40 cc; Product Number: IAB-05840-LWS. The IAB is utilized for intra-aortic balloon counter-pulsation th
  • Z-0969-2011 · Oct 11, 2010 · Terminated
    Percutaneous Insertion Tray For Use with: Arrow Ultra 8 IAB (Intra Aortic Balloon) Catheters Model: IAK-05845
  • Z-0791-2011 · Oct 11, 2010 · Terminated
    Arrow Ultra 8 IAB (Intra-Aortic Balloon) Catheter, 8 Fr, 40cc. Model: IAB-05840-U
  • Z-0792-2011 · Oct 11, 2010 · Terminated
    FiberOptix IAB Sheath, Ultra 8 Fr, 30cc. Model: IAB-05830-LWS
  • Z-0790-2011 · Oct 11, 2010 · Terminated
    Arrow Ultra 8 IAB (Intra-Aortic Balloon) Catheter, 8 Fr, 30cc. Model: IAB-05830-U
  • Z-0793-2011 · Oct 11, 2010 · Terminated
    FiberOptix IAB Ultra 8 Fr, 40cc Model: IAB-05840-LWS
  • Z-1211-2009 · Feb 2, 2009 · Terminated
    8 Fr 40cc Narrow Flex IAB Catheter Kit with Generic Adapters Product Number: IAB-04840-U, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter

…and 12 more.

Other System, balloon, intra-aortic and control devices

All System, balloon, intra-aortic and control devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.